1. Name Of The Medicinal Product
Cobalin-H
2. Qualitative And Quantitative Composition
Anhydrous hydroxocobalamin 1000mcg/ml
3. Pharmaceutical Form
Injection
4. Clinical Particulars
4.1 Therapeutic Indications
Treatment of Addisonian pernicious anaemia.
Prophylaxis and treatment of other macrocytic anaemias due to vitamin B12 deficiency.
Treatment of tobacco amblyopia.
Treatment of Leber's atrophy.
4.2 Posology And Method Of Administration
The following dosages are suitable for children and adults.
Addisonian pernicious anaemia and other macrocytic anaemias without neurological involvement:
Initially: | 250 micrograms to 1000 micrograms intramuscularly on alternate days for one or two weeks then 250 micrograms weekly until blood count is normal. |
Maintenance: | 1000 micrograms every two or three months. |
Addisonian pernicious anaemia and other macrocytic anaemias with neurological involvement:
Initially: | 1000 micrograms by intramuscular injection on alternate days as long as improvement continues. |
Maintenance: | 1000 micrograms every two months. |
Prophylaxis of macrocytic anaemias associated with vitamin B12 deficiency resulting from gastrectomy, ileal resection, certain malabsorption states and vegetarianism:
1000 micrograms every two or three months.
Tobacco amblyopia and Leber's optic atrophy:
Initially: | 1000 micrograms daily by intramuscular injection for two weeks then twice weekly as long as improvement is maintained. |
Maintenance: | 1000 micrograms every three months or as required. |
4.3 Contraindications
Sensitivity to hydroxocobalamin / vitamin B12.
4.4 Special Warnings And Precautions For Use
Cobalin-H should not be given before a megaloblastic marrow has been demonstrated. Regular monitoring of the blood is advisable. Doses of hydroxocobalamin greater than 10 micrograms daily may produce a haematological response in patients with folate deficiency. Indiscriminate use may mask the exact diagnosis. Cardiac arrhythmias secondary to hypokalaemia have been reported during initial therapy and plasma potassium should, therefore, be monitored during this period.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
The serum concentration of hydroxocobalamin may be reduced by concurrent administration of oral contraceptives. Chloramphenicol-treated patients may respond poorly to hydroxocobalamin. Vitamin B12 assays by microbiological techniques are invalidated by antimetabolites and most antibiotics.
4.6 Pregnancy And Lactation
Hydroxocobalamin should not be used to treat megaloblastic anaemia of pregnancy.
4.7 Effects On Ability To Drive And Use Machines
None stated.
4.8 Undesirable Effects
The following effects have been reported and are listed below by body system:
Disorders of the immune system:
Rare: Allergic hypersensitivity reactions
Very Rare: Anaphylaxis
Gastro intestinal disorders:
Frequency Not Known: Nausea
General disorders :
Frequency Not Known: Fever, dizziness, Injection site disorders
Neurological disorders:
Frequency Not Known: Headache
4.9 Overdose
Treatment is unlikely to be needed in cases of overdosage.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Vitamin B12
ATC classification: B03B A03
5.2 Pharmacokinetic Properties
Vitamin B12 is extensively bound to specific plasma proteins called transcobalamins; transcobalamin II appears to be involved in the rapid transport of the cobalamins to tissues. It is stored in the liver, excreted in the bile, and undergoes enterohepatic recycling; part of a dose is excreted in the urine, most of it in the first 8 hours.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sodium dihydrogen orthophosphate
Sodium chloride
Water for Injections
6.2 Incompatibilities
None stated.
6.3 Shelf Life
60 months
6.4 Special Precautions For Storage
Store below 25°C and protect from light.
6.5 Nature And Contents Of Container
Cobalin-H is supplied in clear 1ml Type I glass ampoules in cartons of 5.
6.6 Special Precautions For Disposal And Other Handling
None stated.
7. Marketing Authorisation Holder
Archimedes Pharma UK Limited
250 South Oak Way
Green Park
Reading
Berkshire
RG2 6UG
8. Marketing Authorisation Number(S)
PL 12406/0001
9. Date Of First Authorisation/Renewal Of The Authorisation
November 1998
10. Date Of Revision Of The Text
June 2009
COBINJ5-SPC07
® Cobalin-H is a registered trade mark
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